GlaxoSmithKline (GSK.L) has launched a new trial for a COVID-19 vaccine, while an existing antibody treatment has received an emergency use authorisation from the US.
The pharmaceutical giant, which has been looking to bring a new coronavirus vaccine to the market by the end of the year, announced on Thursday that it has initiated a global phase three clinical efficacy study.
The vaccine could be approved in the fourth quarter of 2021 pending positive outcomes and regulatory reviews, the company said. Manufacturing will begin in the coming week to enable rapid access to the vaccine should it be approved.
The company, which is lagging behind its rivals in the fight against coronavirus, has partnered with French firm Sanofi.
The new trial follows the interim phase two results which showed that their vaccine candidate achieved high rates of neutralising antibody responses in all adult age groups, with 95% to 100% seroconversion rates.
After a single injection, high neutralising antibody levels were also generated in participants with evidence of prior infection, which suggests strong potential for development as a booster vaccine, GSK said.
"We believe further solutions for COVID-19 are very much needed to help reach people around the world, especially as the pandemic evolves and variants continue to emerge,” said Roger Connor, president of GSK vaccines.
“Adjusting our technology and study designs reflects this need and will further build the potential of this adjuvanted protein-based vaccine. We are grateful to the volunteers who will take part in the trials and hope the results will add to the encouraging data we've seen so far so we can make the vaccine available as quickly as possible.”
The GSK vaccine was originally expected to receive regulatory approval in the first half of this year, however, it was delayed in December as it failed to produce a strong immune response in older people.
The UK had pre-ordered around 60 million doses of the GSK-Sanofi vaccine as of December.
The news came as an antibody treatment called sotrovimab received an emergency green light from the US Food and Drug Administration (FDA) to treat mild-to-moderate COVID-19 in people 12 years of age and older.
GSK revealed that treatment with sotrovimab resulted in an 85% reduction in the risk of hospitalisation or death in high-risk adult outpatients compared to placebo, based on interim results from Phase 3 COMET-ICE trial.
It will be available for patients diagnosed with COVID-19 in the US in the coming weeks, while discussions with global regulators in additional countries continue. The antibody drug is not authorised for patients who require oxygen therapy.
The news comes as Emma Walmsley, GSK’s chief executive, has been put under pressure after activist investor Elliott Management took a multibillion-pound stake in the company in April.
According to the Times on Thursday, Elliott Management will not push for a sale of GSK’s vaccines and pharmaceuticals business. It is also understood that it is not planning to push for cuts to the company’s £5bn ($7bn) research and development budget, and will be supportive of GSK remaining in the UK.
Watch: GlaxoSmithKline closer to splitting in two